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The European Medicines Agency accepts the marketing authorization application (MAA) of Enfortumab Vedotin

 Last Update: 2021-04-13
 Source: Internet
 Author: User

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Pharmaceutical company Astellas and Seagen recently announced, enfortumab vedotin the marketing authorization application (MAA) has been the European Medicines Management Agency (EMA) accepted.

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Enfortumab vedotin will be reviewed in an accelerated evaluation, which means that the EMA's Committee on Medicines for Human Use (CHMP) can shorten the evaluation time.

MAA's approval is based on the global Phase III EV-301 trial, which evaluated the efficacy of enfortumab vedotin in the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received platinum-based chemotherapy and PD-1/L1 inhibitors.

The results of the trial were published in the New England Journal of Medicine, and the primary endpoint of the trial was overall survival.

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